Department of Health and Human Services February 2, 2006 – Federal Register Recent Federal Regulation Documents
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National Emerging Infectious Diseases Laboratories Record of Decision
The Department of Health and Human Services, the National Institutes of Health (NIH), has decided, after completion of a Final Environmental Impact Statement (FEIS) and a thorough consideration of the public comments on the Draft EIS and Supplemental EIS, to implement the Proposed Action, which is identified as the Preferred Alternative in the Final EIS. This action is to partially fund the construction of a state-of-the-art National Biocontainment Laboratory (NBL), to be called the National Emerging Infectious Diseases Laboratories (NEIDL), at the Boston University Medical Center (BUMC) Campus in Boston, Massachusetts.
Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability
The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for INVANZ (ertapenem), KEPPRA (levetiracetam), TRILEPTAL (Oxcarbazepine), and ZYVOX (linezolid). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act (BPCA). For all pediatric supplements submitted under the BPCA, the BPCA requires FDA to make available to the public a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement.
Determination of Regulatory Review Period for Purposes of Patent Extension; OMACOR
The Food and Drug Administration (FDA) has determined the regulatory review period for OMACOR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of three applications to the Director of Patents and Trademarks, Department of Commerce, for the extension of three patents that claim that human drug product.
Determination That CLARITIN (Loratadine) Hives Relief Syrup, 5 Milligrams per 5 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined that CLARITIN (loratadine) Hives Relief syrup, 5 milligrams (mg) per (/) 5 milliliters (mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for loratadine hives relief syrup, 5 mg/ 5mL.
Determination of Regulatory Review Period for Purposes of Patent Extension; ALOXI
The Food and Drug Administration (FDA) has determined the regulatory review period for ALOXI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent that claims that human drug product.
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